What are the responsibilities and job description for the Manufacturing Technician - Cleanroom Operations position at Lyra Therapeutics?
Job Summary
We are seeking a highly skilled Manufacturing Technician to join our team at Lyra Therapeutics. As a key member of our production team, you will be responsible for manufacturing drug products in a cleanroom environment, adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Key Responsibilities
- Manufacture drug products in a cleanroom environment, following all relevant SOPs, batch records, and work instructions.
- Adhere to GMP and GDP principles when executing all assignments, including batch records, lab notebooks, and logbooks.
- Work collaboratively with the engineering and QA/QC departments to troubleshoot and solve production-related issues.
- Mentor and train employees with less experience on GMP and manufacturing steps.
- Perform solution preparation for chemical processes, fixture setup, spray-coating, packaging, heating/drying, and microscope visual inspection activities.
- Setup and operate equipment, monitor performance, and report any abnormal equipment or product conditions.
- Maintain a clean, safe, and orderly work area and equipment.
- Perform routine testing of product/WIP to produce reliable and precise data to support product development.
Requirements
- Associate's degree or Bachelor's degree in Science or Engineering.
- 5 to 10 years of related industrial experience in medical device or biotech manufacturing.
- Experience with polymeric spray coatings and working knowledge of spray coating technology is a plus.
- Proficient with basic lab skills and lab equipment, with the ability to safely work with chemicals and solvents.
- Ability to work under the direction of supervisors and management, provide on-the-floor supervision when needed, and effectively interact with various groups and personnel.
- Ability to adhere to GMP and GDP practices.
- Flexibility to work within a small team without strictly defined roles, and ability to manage time effectively.
- Solid skills in Microsoft Office (Word and Excel).
- Demonstrated commitment to safety.
- Availability to work 40 hours per week, with a flexible schedule to meet project demands.
